The purpose of the current randomized clinical trial was to analyze the effectiveness of craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid in individuals with chronic low back pain.
Objective: To analyze the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with chronic low back pain. Design: A single blinded randomized controlled trial. Setting: Clinical setting. Subjects: Sixty-four patients (42 females) with chronic low back pain. Interventions: Patients were randomly assigned to an experimental group (craniosacral therapy group) or a control group (classic massage group). Main measures: Self-reported disability (Roland Morris Disability Questionnaire - primary outcome; and Oswestry Disability Index), pain intensity (a 10-point Numerical Pain Rating Scale), scale of kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade Test), lumbar mobility in flexion, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Universidad de Almeria
Almería, Almería, Spain
Roland-Morris Disability Questionnaire (RMQ)
It is one of the most used questionnaires for assessing disability due to LBP. This is a self-reported questionnaire consisting of 24 items reflecting limitations in different activities of daily living attributed to LBP including walking, bending over, sitting, lying down, dressing, sleeping, self-care and daily activities.
Time frame: Changes in 10 weeks and 14 weeks
Oswestry Low Back Pain Disability Index (ODI).
The ODI has 10 items referring to activities of daily living that might be disrupted by LBP. Each item is answered on a 6-point Likert scale ranging from "no problem at all" \[0\] to "not possible" \[5\]. The total score ranges from 0 to 50.
Time frame: 10 weeks and 14 weeks
10-point Numerical Pain Rating Scale
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) was used to assess the patients' current level of pain, and the worst and lowest level of pain experienced in the preceding 24 hours.
Time frame: 10 weeks and 14 weeks
Tampa Scale of Kinesiophobia (TSK)
The Tampa Scale of Kinesiophobia (TSK) is a 17-item questionnaire developed to measure the fear of movement and (re)injury.
Time frame: 10 weeks and 14 weeks
Isometric endurance of trunk flexor muscles
To test isometric endurance of trunk flexor muscles we used the McQuade test. Subjects were supine with their arms crossed over the chest, hands on the opposite shoulders, hips bent, and knees and feet apart. They were asked to nod and continue to lift their head and shoulders until the inferior angle of the scapula lifted from the table and maintain the position as long as possible.
Time frame: 10 weeks and 14 weeks
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Lumbar mobility in flexion
Lumbar mobility in flexion was determined by measuring the finger-to-floor distance with a tape.
Time frame: 10 weeks and 14 weeks
Hemoglobin Oxygen Saturation
This outcome measure will be assess with Electro Intersticial Scanner
Time frame: 10 weeks and 14 weeks
Systolic Blood Pressure
This outcome measure will be assess with Electro Intersticial Scanner
Time frame: 10 weeks and 14 weeks
Diastolic Blood Pressure
This outcome measure will be assess with Electro Intersticial Scanner
Time frame: 10 weeks and 14 weeks
Hemodynamic (Cardiac Index)
This outcome measure will be assess with Electro Intersticial Scanner
Time frame: 10 weeks and 14 weeks
Insterticial Liquid Biochemical Estimation
This outcome measure will be assess with Electro Intersticial Scanner
Time frame: 10 weeks and 14 weeks